Safety and Immunogenicity of an HIV Vaccine in Normal Adult Volunteers

NCT00083330 | Completed Phase 1

• 2 other identifiers: 04017204-I-0172
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

Brief Summary

This study will test the safety of an experimental vaccine against HIV infection and see if it causes an immune response to HIV. The vaccine is given by injection (shot) in the upper arm. It is made from DNA that codes for three HIV proteins. The DNA is inserted into an adenovirus that carries it into the muscle cells. The adenovirus normally can cause eye or upper respiratory infections, such as a cold; however, for the vaccine, it has been modified so that it cannot cause illness. Nor can the vaccine cause HIV infection, because it codes for only three of the nine HIV proteins. Healthy, normal volunteers between 18 and 44 years of age who are not HIV-infected may be eligible for this study. Candidates are screened with a medical history and physical examination and blood and urine tests. Participants are randomly assigned to receive either the experimental vaccine or a placebo (an inactive substance that looks like the vaccine). The vaccine or placebo is administered to participants in groups, according to their entry into the study. The first group receives the lowest study dose of vaccine. If this dose is safe, then the second group receives a higher dose. If this dose is also safe, then the third and final group receives the highest study dose. Clinic staff observe the subjects for side effects for 30 minutes after the injection, and subjects keep a diary card for the next 5 days, recording their temperature and any symptoms that may appear. Subjects are contacted by a nurse 2 days after the injection for follow-up. Participants are seen at the clinic for follow-up visits 1, 2, 4, 12, and 24 weeks after the injection, and then are contacted by telephone for follow-up once a year until 5 years after the injection. The clinic visits include a physical examination, medical history, blood and urine tests, and HIV counseling, as needed. Women have pregnancy tests at the screening evaluation and again at study week 24. All subjects are tested for HIV at screening and at study weeks 12 and 24, and all subjects complete a "social impact questionnaire" at week 24. All subjects are asked questions about their sexual behavior and drug use. ...

Conditions

Healthy; HIV Infections

Keywords

Healthy; T Cells; Immunity; Healthy Volunteer; HV

Interventions

VRC-HIVADV014-00-VP DRUG

Eligibility Criteria

• Age: 18 Years - 44 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A participant must meet all of the following criteria:
• to 44 years old.
• Available for clinical follow-up through Week 24 and telephone or mail contact for an additional 4 years.
• Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
• Complete an Assessment of Understanding prior to enrollment and verbalize understanding of all questions answered incorrectly.
• Able and willing to complete the informed consent process.
• Willing to receive HIV test results and willing to abide by NIH guidelines for partner notification of positive HIV results.
• Willing to donate blood for sample storage to be used for future research.
• Willing to discuss HIV infection risks and amenable to risk reduction counseling.
• In good general health without clinically significant medical history.
• Physical examination and laboratory results without clinically significant findings within the 28 days prior to enrollment.
• Laboratory Criteria within 28 days prior to enrollment:
• Hemoglobin is greater than or equal to 11.5 g/dL for women; greater than or equal to 13.5 g/dL for men
• WBC is equal to 3,300-12,000 cells/mm(3)
• Differential either within institutional normal range or accompanied by site physician approval

You may not qualify if:

• A volunteer will be excluded if one or more of the following conditions apply.
• Women:
• Breast-feeding.
• Volunteer has received any of the following substances:
• HIV vaccines in a prior clinical trial
• Immunosuppressive or cytotoxic medications within the past six months with the exception of corticosteroid nasal spray for allergic rhinitis or topical corticosteroids for an acute uncomplicated dermatitis
• Blood products within 120 days prior to HIV screening
• Immunoglobulin within 60 days prior to HIV screening
• Live attenuated vaccines within 30 days prior to initial study vaccine administration
• Investigational research agents within 30 days prior to initial study vaccine administration
• Medically indicated subunit or killed vaccines, e.g. influenza, pneumococcal, or allergy treatment with antigen injections, within 14 days of study vaccine administration
• Current anti-TB prophylaxis or therapy
• Volunteer has a history of any of the following clinically significant conditions:
• Serious adverse reactions to vaccines such as anaphylaxis, hives, respiratory difficulty, angioedema, or abdominal pain
• Autoimmune disease or immunodeficiency

Sponsors & Collaborators

• National Institute of Allergy and Infectious Diseases (NIAID): lead

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (4)

• Borrow P, Lewicki H, Hahn BH, Shaw GM, Oldstone MB. Virus-specific CD8+ cytotoxic T-lymphocyte activity associated with control of viremia in primary human immunodeficiency virus type 1 infection. J Virol. 1994 Sep;68(9):6103-10. doi: 10.1128/JVI.68.9.6103-6110.1994.

  PMID: 8057491 BACKGROUND

• Koup RA, Safrit JT, Cao Y, Andrews CA, McLeod G, Borkowsky W, Farthing C, Ho DD. Temporal association of cellular immune responses with the initial control of viremia in primary human immunodeficiency virus type 1 syndrome. J Virol. 1994 Jul;68(7):4650-5. doi: 10.1128/JVI.68.7.4650-4655.1994.

  PMID: 8207839 BACKGROUND

• Pantaleo G, Demarest JF, Soudeyns H, Graziosi C, Denis F, Adelsberger JW, Borrow P, Saag MS, Shaw GM, Sekaly RP, et al. Major expansion of CD8+ T cells with a predominant V beta usage during the primary immune response to HIV. Nature. 1994 Aug 11;370(6489):463-7. doi: 10.1038/370463a0.

  PMID: 8047166 BACKGROUND

• Catanzaro AT, Koup RA, Roederer M, Bailer RT, Enama ME, Moodie Z, Gu L, Martin JE, Novik L, Chakrabarti BK, Butman BT, Gall JG, King CR, Andrews CA, Sheets R, Gomez PL, Mascola JR, Nabel GJ, Graham BS; Vaccine Research Center 006 Study Team. Phase 1 safety and immunogenicity evaluation of a multiclade HIV-1 candidate vaccine delivered by a replication-defective recombinant adenovirus vector. J Infect Dis. 2006 Dec 15;194(12):1638-49. doi: 10.1086/509258. Epub 2006 Nov 8.

  PMID: 17109335 DERIVED

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: May 20, 2004
• First Posted: May 20, 2004
• Study Start: May 18, 2004
• Primary Completion: October 1, 2009
• Study Completion: October 1, 2009
• Last Updated: July 2, 2017

Record last verified: 2009-10-01

Locations

US (1)